(170 days)
DAILIES AquaComfort Plus (nelficion A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES AquaComfort Plus FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
Dailies AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 6.00 diopters (D) of astigmatism.
Dailies AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of presbyopia with or without refractive ametropia) in phakic or aphakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. the lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal are soft contact lenses intended for the optical correction of refractive error.
They are available in spherical, toric and multifocal designs as applicable:
- Spherical lenses: DAILIES AquaComfort Plus
- Aspherical lenses: DAILIES AquaComfort Plus FreshTech
- Toric lenses: DAILIES AquaComfort Plus Toric
- Multifocal lenses: DAILIES AquaComfort Plus Multifocal
The lens material is nelfilcon A, a high water non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide) and 69% water. The material further contains non-functionalized PVA (high- and or Ultra molecular weight PVA) and the color additive phthalocyanine green (CFR 73.3124).
DAILIES AquaComfort Plus products are supplied sterile. The lenses are immersed in buffered saline solution and are packaged in individual foil-blister packs as primary packaging and terminally sterilized in a validated autoclave (moist heat, steam under pressure). The blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material. The lenses are supplied in strips of five foiled sealed blister packs each containing approximately 0.65 ml of phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. The package saline additionally contains the comfort additives hydroxypropylmethyl cellulose (HMPC) and polyethyleneglycol 400 (PEG 400). Sealed blister strips are provided in secondary packaging carton boxes containing 5, 30 or 90 lenses each.
The provided text describes the 510(k) premarket notification for various DAILIES AquaComfort Plus contact lenses. It mainly focuses on demonstrating substantial equivalence to previously cleared devices rather than robust clinical studies as typically seen for AI/ML-based devices.
Therefore, many of the requested categories, such as sample size for test sets, expert credentials, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this document. This submission relies on non-clinical testing and similarity to predicate devices for its approval.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in the format typically used for performance metrics like sensitivity, specificity, etc., for AI/ML devices. Instead, it compares the technological characteristics and performance specifications to predicate devices. The "acceptance criterion" for these parameters is essentially "Same" as the predicates or meeting established industry standards.
| Element of Comparison | Predicate Devices Performance | Modified Device Performance | Acceptance Criteria (Implied) |
|---|---|---|---|
| Administrative/Regulatory | |||
| 510(k) Number | K963487, K072777, K172066, K180398 | To be assigned (K181454 upon clearance) | N/A |
| Product Name | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal | DAILIES AquaComfort Plus FreshTech (and the others are modifications of these) | N/A |
| Device Classification | Class II, Daily Wear Soft (Hydrophilic) Contact Lenses | Same | Same Classification |
| Indications for Use | |||
| Intended Use | One-Day contact lenses for optical correction of vision. Single use, daily disposable wear. (Specifics vary by lens type - spherical, toric, multifocal) | Same | Same Indications |
| Technology Information | |||
| Lens Material | nelfilcon A | Same | Same Material |
| Water Content | 69% | Same | 69% |
| Visibility Tint | Light blue (copper phthalocyanine blue) | Same | Same Tint |
| Manufacturing Method | Lightstream Technology: Full mold cast | Same | Same Method |
| Lens Design | Spherical, Toric, Multifocal | Aspheric (for DAILIES AquaComfort Plus FreshTech), and spherical, toric, multifocal for the others | Spherical, Toric, Multifocal, Aspheric |
| Sterilization | Steam sterilization, validated autoclave | Same | Same Sterilization |
| Primary Packaging System | Foil blister pack container system; Polypropylene blister shell sealed with a polyester coated aluminum foil lidding | Same | Same Packaging System |
| Primary Packaging Blister Shell | Injection-molded polypropylene blister shell made from Flint Hills Resources P4C5N-046 Polypropylene or Formosa 4142T polypropylene | Same | Same Shell Material |
| Primary Packaging Foil Lidding | Multilayer laminate structure polyester coated aluminum foil lidding supplied by Constantia-Hueck Folien and/or Huhtamaki foil | Same | Same Lidding Material |
| Package Storage/Saline Solution | Phosphate-acetate buffered saline with up to 0.05% Poloxamer 108. Additionally contains PEG and HPMC | Same | Same Solution |
| Performance Specifications | |||
| Refractive Index | 1.38 (hydrated) | Same | 1.38 (hydrated) |
| Light Transmittance | ≥ 92%T @ 610 nm | Same | ≥ 92%T @ 610 nm |
| Oxygen Permeability (Dk) | 26 x 10-11 (cm²/s) ml O₂/ml x mmHg) measured at 35°C (Fatt, edge effect corrected) | Same | 26 x 10-11 Dk |
| Elastic Modulus | 0.9 MPa | Same | 0.9 MPa |
| Biocompatibility | Biocompatible as confirmed by appropriate biocompatibility testing | Same (confirmed by testing) | Biocompatible |
| Shelf-life | Up to 60 months as confirmed by shelf-life stability testing | Same (confirmed by testing) | Up to 60 months |
2. Sample size used for the test set and data provenance:
- Not Applicable. The submission states that due to the similarity of the modified device to the predicate device and successful non-clinical testing, clinical testing was not required to establish substantial equivalence. Therefore, there is no "test set" in terms of patient data for performance evaluation in a clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No clinical test set where "ground truth" would be established by experts was used.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set requiring adjudication was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs. without AI assistance:
- Not Applicable. This is not an AI/ML-based device. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/ML-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For non-clinical testing, "ground truth" is typically defined by laboratory standards and measurements for physical and chemical properties (e.g., precise measurement of water content, refractive index, sterility confirmation).
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI/ML device.
Study Proving Acceptance Criteria Met:
The study that proves the device meets the acceptance criteria is detailed under "VII. Performance Data" and "VIII. Conclusions." This is a collection of non-clinical tests and analyses rather than a single clinical study.
- Biocompatibility Testing: "Test results from a series of in vitro and in vivo biocompatibility evaluations, including cytotoxicity, ocular irritation and systemic toxicity testing confirm that the minor device modification does not negatively impact the safety of the devices. The modified device is non-toxic and biocompatible. All biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58) and relevant ISO 10993 series biocompatibility standards."
- Sterilization: "Based on the similarity of the packaging materials and the successful completion of sterilization testing in accordance with FDA guidance and the applicable requirements of ISO 17665-1:2006."
- Stability Testing: "Successful stability testing supports the labeled expiration date for the modified device."
- Physico-chemical, dimensional, and optical properties: The document states that these were evaluated and "demonstrate that the aspheric lens design meets specifications." While specific test methods and results are not detailed in this summary, they would have been submitted to the FDA.
Conclusion:
The submission concludes that "The results of device performance testing evaluation including physico-chemical, biocompatibility, sterilization and stability and the qualification of the dimensional and optical properties demonstrate that the aspheric lens design meets specifications. The results supports the substantial equivalence of the device to the predicate device."
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.